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IRCT20160625028627N3 IRCT 2025-05-27 Sanandaj University of Medical Sciences Comparison of the effect of Empagliflozin and Sitaglipin, as add on to metformin on diabetes treatment Comparison of the effect of Empagliflozin and Sitaglipin, as add on to metformin on Fetuin-A serum level and insulin resistance in patient with type 2 diabetes 2025-06-20 anticipated 74 Complete https://irct.ir/trial/83399 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: Stratified permuted block randomization (block sizes: 4, 6) to ensure balanced allocation. Unit of randomization: Individual participants. Randomization strata: age (less than 50 years versus age greater than or equal to 50 years), sex, and duration of diabetes (greater than or equal to 5 years versus less than 5 years). Randomization tool: Computer-generated random sequences (statistical software), with separate sequences per stratum. Random sequence generation: Software-produced sequences ensured unpredictability within blocks. Allocation concealment: Maintained via an independent researcher using sequentially numbered, opaque envelopes or a secure electronic system, Blinding description: In this study, three main groups including outcome assessors (who measure outcomes without knowledge of group allocation), data analysts (who do not have access to grouping information), and the Data and Safety Monitoring Board (who only access allocation information when necessary) were kept blinded to participant allocation to prevent bias. Evaluations were based on coded data and analyses were performed independently. 2 Type 2 diabetes. Intervention 1: Intervention group 1 (Empagliflozin + Metformin Group):In the first group, patients with type 2 diabetes who failed to achieve adequate glycemic control (HbA1c 7.5-8.5%) despite at least 3 months of metformin monotherapy (at a fixed dose) received combination therapy with empagliflozin and metformin. Empagliflozin was administered at a fixed dose of 10 mg once daily. Metformin was initiated at 500 mg daily and gradually titrated (with weekly 500 mg increments) up to a maximum dose of 2000 mg daily. Dose escalation was based on patient tolerance and therapeutic response. Renal function (eGFR) was assessed in all patients before treatment initiation and throughout the study, and metformin was discontinued if eGFR fell below 30 mL/min/1.73m². Intervention 2: Intervention group 2 (Sitagliptin + Metformin Group):In the second group, patients with similar characteristics (uncontrolled type 2 diabetes with metformin monotherapy and HbA1c 7.5-8.5%) received combination therapy with sitagliptin and metformin. Sitagliptin dosage was adjusted based on renal function: 100 mg daily for eGFR≥50, 50 mg daily for eGFR 30-49, and 25 mg daily for eGFR<30. The metformin administration protocol in this group was identical to the first group (starting at 500 mg with gradual increase up to 2000 mg daily). All patients underwent renal function assessment before treatment initiation, and drug dosages were individually adjusted according to clinical and laboratory parameters. Metformin was discontinued if renal function declined below 30 mL/min/1.73m². Yes - There is a plan to make this available What will be shared: The fully anonymized participant data will be shareable upon reasonable request after study completion. The shareable materials include the following: The dataset will include non-identifiable clinical parameters such as HbA1c, blood pressure, and lipid profiles. It should be noted that all personally identifiable information including names, IDs, and contact details will be permanently removed. In the documentation section, the study protocol in both Farsi and English, data collection forms as blank templates, and educational materials including video scripts and booklet content will be made available. The access conditions for this data are such that six months after study publication, the data will become accessible. Requesters must comply with the following requirements: a) Submission of a formal research proposal b) Signing a data use agreement that prohibits re-identification c) Proper source attribution in their publications When: Data will be available 6 months post-publication. To whom: The study data and documents will be accessible to both of the following groups: A) Academic researchers: University faculty members, Research institute scientists, Graduate students (with supervisor approval). B) Industry/clinical professionals: Practicing physicians and nurses, Pharmaceutical/medical device specialists, Research & Develpment specialists in health-related companies. Conditions: Access to de-identified data and study documents is subject to the following requirements: a) General Conditions: Submission of formal request including research objectives, analysis plan and timeline, Approval by the ethics committee of requester's institution, Signed limited data use agreement. b) Analytical Restrictions: Any statistical analysis is permitted provided it doesn't enable indirect identification, Subgroup comparisons require minimum 10 cases per group, Machine learning applications need separate approval. c) Usage Permissions: Permitted for academic research and therapeutic protocol development, Commercial use requires separate licensing agreement, Educational materials may be redistributed with proper attribution. d) Oversight Mechanisms: Mandatory progress reports every 6 months, Periodic audits by independent data monitor, Data deletion commitment after project completion. Where to obtain: Interested parties may submit their requests for study data and documentation to the following email address: golnaz.azami64@gmail.com How to obtain: Request Procedure: Formal Request Submission: Complete request form (if applicable), Email to golnaz.azami64@gmail.com with clear subject. Attach: -Research proposal, -Ethics approval, -Affiliation documents. *Initial Review (3-5 business days): -Document completeness check, -Research objectives alignment assessment, *Technical Evaluation (7-10 business days): -Analysis plan review by technical team, -Access level determination, -De-identified data preparation. *Agreement Finalization (5-7 business days): -NDA signing, -Usage terms confirmation. -Cost determination (if applicable). *Data Delivery (2-3 business days post-agreement): -Secure platform transfer, -User guide provision, -Analysis restrictions specification, Total Processing Time: 15-25 business days (depending on request complexity). Comments:
public Dr. Golnaz Azami
Pasdaran Boulevard, Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4664 golnaz.azami64@gmail.com Sanandaj University of Medical Sciences scientific Golnaz Azami
Pasdaran Boulevard, Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617913446 +98 918 344 6450 golnaz.azami64@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Diagnosed with type 2 diabetes for a minimum of 6 months and a maximum of 10 years Body mass index greater than or equal to 25 No acute illness in the past 6 months Patients must have been on stable-dose metformin monotherapy for the past 3 months, yet their blood glucose remains uncontrolled (outside target range), demonstrating metformin resistance, with hemoglobin A1c levels between 7.5-8.5% 18 years no limit Both Development of type 2 diabetes complications that disrupt care (e.g., blindness, dialysis, severe stroke) Medical history of cognitive disorders (e.g., dementia, Alzheimer’s) Uncontrolled hypertension more than 180/110 millimeters of mercury Hemolytic anemia Hemoglobinopathies Any change in type/dose of prescribed diabetes medications during the 3-month study period Patients with a history of fatty liver disease Concurrent use of antioxidant or anti-inflammatory drugs Patients with thyroid disorders E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group 1 (Empagliflozin + Metformin Group):In the first group, patients with type 2 diabetes who failed to achieve adequate glycemic control (HbA1c 7.5-8.5%) despite at least 3 months of metformin monotherapy (at a fixed dose) received combination therapy with empagliflozin and metformin. Empagliflozin was administered at a fixed dose of 10 mg once daily. Metformin was initiated at 500 mg daily and gradually titrated (with weekly 500 mg increments) up to a maximum dose of 2000 mg daily. Dose escalation was based on patient tolerance and therapeutic response. Renal function (eGFR) was assessed in all patients before treatment initiation and throughout the study, and metformin was discontinued if eGFR fell below 30 mL/min/1.73m². Intervention group 2 (Sitagliptin + Metformin Group):In the second group, patients with similar characteristics (uncontrolled type 2 diabetes with metformin monotherapy and HbA1c 7.5-8.5%) received combination therapy with sitagliptin and metformin. Sitagliptin dosage was adjusted based on renal function: 100 mg daily for eGFR≥50, 50 mg daily for eGFR 30-49, and 25 mg daily for eGFR<30. The metformin administration protocol in this group was identical to the first group (starting at 500 mg with gradual increase up to 2000 mg daily). All patients underwent renal function assessment before treatment initiation, and drug dosages were individually adjusted according to clinical and laboratory parameters. Metformin was discontinued if renal function declined below 30 mL/min/1.73m². Mean serum fetuin-A level. Timepoint: Serum fetuin-A levels will be measured before the intervention and at week 12. Method of measurement: The blood test using the ELISA method. Mean change in insulin resistance. Timepoint: Mean change in insulin resistance will be measured before the intervention and at week 12. Method of measurement: Blood test using ELISA kit (HOMA-IR index). Mean change in fasting blood glucose levels. Timepoint: Mean change in fasting blood glucose levels will be measured before the intervention and week 12 post-intervention. Method of measurement: The blood test will be performed using a glucometer. Mean change in glycated hemoglobin. Timepoint: Mean change in glycated hemoglobin will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test-measured by high-performance liquid chromatography/HPLC. Mean change in serum triglyceride levels. Timepoint: Mean change in serum triglyceride levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method. Mean change in serum total cholesterol levels. Timepoint: Mean change in serum total cholesterol levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method. Mean change in serum HDL levels. Timepoint: Mean change in serum HDL levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method. Mean change in serum LDL levels. Timepoint: Mean change in serum LDL levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method. Mean change in body mass index (kg/m²). Timepoint: Mean change in body mass index will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Measurements will be performed by trained staff using calibrated digital scales (accuracy 0.1 kg) and standard stadiometers (accuracy 0.5 cm). Sanandaj University of Medical Sciences Approved 2025-02-16 Ethic committee of Kurdistan University of Medical Sciences Pasdaran Boulevard, Kurdistan University of Medical Sciences, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)